Iron supplementation of breastfed Gambian infants from 6 weeks to 6 months of age: protocol for a randomised controlled trial.
Iron supplementation of breastfed Gambian infants from 6 weeks to 6 months of age: protocol for a randomised controlled trial.
复制标题
对母乳喂养的冈比亚婴儿的补充6周至6个月大：随机对照试验的方案。
DOI：
10.12688/wellcomeopenres.17507.1
复制
发表时间：
2022
影响因子：
--
通讯作者：
中科院分区：
文献类型：
--
作者：
背景资料：最近的一项分析表明，冈比亚婴儿的血浆铁浓度从出生起就迅速下降，无论性别或出生体重如何，其浓度远低于两个月以上铁充足儿童的正常预期值（通常>10 μmol/L）。因此，神经和免疫细胞的发育和功能可能会在世界卫生组织建议的儿童应接受铁补充剂的最低年龄之前受到损害。 方法：本研究是一项双组、双盲、安慰剂对照、随机优效性试验。婴儿将随机接受每日一次铁滴（7.5 mg/天硫酸亚铁形式的铁）或安慰剂，持续98天，以测试对入组时6-10周龄健康母乳喂养婴儿（n = 100）血清铁浓度的影响。将每天对参加者进行访问，并由实地工作队提供补充。将进行每日健康和每周母乳喂养问卷调查。将在入组时和补充血清铁98天后采集人体测量、静脉血和粪便样本作为主要终点。不排除低出生体重（出生时小于2.5 kg）和早产儿（< 37周）。配方奶粉喂养的婴儿和患有任何疾病的婴儿将被排除在外。将通过与产妇面谈和与当地利益攸关方的四次重点小组讨论，开展另一项研究，探讨产妇利益攸关方对干预措施的看法。 讨论：大多数母乳喂养的冈比亚婴儿在5个月大时循环铁水平非常低。这项研究将在婴儿期引入铁补充剂，比以前在低收入环境中尝试的要早得多，主要目的是增加血清铁浓度。 试验注册：Clincaltrials.gov（NCT 04751994）; 2021年2月12日
Background: A recent analysis showed that plasma iron concentrations decline rapidly from birth in Gambian infants, irrespective of sex or birthweight, to concentrations well below normal expected values for iron-replete children older than two months of age (typically >10 μmol/L). The development and function of neural and immune cells may thus be compromised before the minimum age at which children should receive iron supplementation as per World Health Organisation recommendations. Methods: This study is a two-arm, double-blind, placebo-controlled, randomised superiority trial. Infants will be randomised to receive iron drops (7.5mg/day of iron as ferrous sulphate) or placebo daily for 98 days, to test the impact on serum iron concentrations in healthy, breastfed infants (n = 100) aged 6-10 weeks at enrolment. Participants will be visited daily and supplemented by the field team. Daily health and weekly breastfeeding questionnaires will be administered. Anthropometry, and venous blood and faecal samples will be collected at enrolment and after 98 days of supplementation with serum iron as the primary endpoint. Low birthweight (less than 2.5kg at birth) and infants born prematurely (< 37 weeks) will not be excluded. Formula-fed and infants with any illness will be excluded. An additional study exploring maternal stakeholder perspectives of the intervention will be conducted by means of maternal interviews and four focus group discussions with local stakeholders. Discussion: Most breast-fed Gambian infants have very low circulating iron levels by five months of age. This study will introduce iron supplements much earlier in infancy than has previously been attempted in a low-income setting with the primary aim of increasing serum iron concentration. Trial registration: Clincaltrials.gov ( NCT04751994); 12 th February 2021